GDP responsibilities in outsourced transport: who remains responsible for what when a carrier drives

The GDP guidelines are addressed to the wholesaler. Chapter 9 opens with it: the supplying wholesaler is responsible for protecting medicines during transport against breakage, falsification and theft, and for keeping the temperature within acceptable limits. It does not say 'unless the transport is outsourced'. The IGJ puts it plainly in its questions on the guidelines: a wholesaler or manufacturer cannot transfer the responsibility for transport to a carrier by contract; it can make arrangements and record them.

Outsourcing and transferring are therefore two different things. Outsourcing is having someone else do the work, under arrangements and supervision. Transferring would mean that the other party takes over the duty and the wholesaler is relieved of it. The latter is not possible, because the duty is attached to the wholesale distribution authorisation: the European medicines directive and the Dutch Medicines Act place compliance with GDP on the authorisation holder, and a carrier without an authorisation is not an addressee of that duty. So it cannot take it over either. What a carrier can and cannot say about GDP is explained in GDP training or GDP certificate.

Chapter 7 describes the outsourcing of any activity covered by GDP. The contract giver remains responsible for what it outsources. It assesses beforehand whether the contract acceptor is suitable, concludes a written contract with a clear division of tasks, may audit before the start and at any later moment, and gives the contract acceptor the information needed to do the work in line with the requirements. For transport, chapter 9 adds that the wholesaler informs the carrier of the transport conditions and that the contract includes the requirements of chapter 7.

The wholesaler plans transport on the basis of a risk assessment, trains its own staff, with specific attention to temperature-sensitive products, and makes sure that storage conditions during transport stay within the limits of the manufacturer or the outer packaging. It does not set those limits itself: they come from the manufacturer and are printed on the pack. It passes them on. How that works in the daily chain of pharmacy and wholesaler is explained in medicine transport.

Under chapter 7 the contract acceptor, here the carrier, must have the premises, equipment, knowledge and experience to do the work properly. It passes on information that may affect the quality of the product, and it does not subcontract anything without the contract giver having assessed and approved it and being able to audit the third party. Its concrete tasks come from chapter 9: keep the condition, report deviations to the distributor and the recipient, and deliver to the addressee at the address on the delivery note.

According to the IGJ, a carrier that only transports and holds medicines at a location for less than 72 hours needs no wholesale distribution authorisation; one that structurally stores them for 72 hours or longer does. In both cases it observes the GDP rules on personnel, storage and transport, under the supervision of its client, who arranges that with a written agreement and audits. The guidelines describe transport as moving medicines between two locations without storing them for unnecessarily long; what stands still for longer becomes storage, and different requirements apply to that.

The guidelines prescribe no model contract, but chapters 7 and 9 make clear what has to be arranged in any case. A contract that misses these points leaves a gap that becomes visible during an inspection or a damage claim.

• Which tasks the carrier performs and which the wholesaler keeps itself.
• The transport conditions per product or product group, and where they come from: the label, the manufacturer or an instruction from the client.
• How and to whom a deviation is reported, and how quickly.
• The client's right to audit, before the start and during the term.
• The prohibition on subcontracting the work without assessment and approval by the client.
• The carrier's duty to pass on information that may affect quality.
• Delivery to the addressee at the address on the delivery note, and what happens if the addressee is absent.
• Which records the client wants to see: times, who signed, and temperature information on request.

Chapter 7 is strict here: the contract acceptor may not subcontract the work to a third party without the contract giver having assessed and approved the arrangement in advance and being able to audit the third party. The chain of responsibility stays with the wholesaler; every link below it works under a contract that passes on the same requirements. A client who does not know who is actually driving therefore has no view of its own obligation.

In practice this is the question to ask every carrier: do you drive yourself, or do you engage someone else when busy, and will I know? The answer determines whether the contract and the audits cover the whole chain.

Chapter 9 requires a deviation from the storage conditions during transport to be reported to the distributor and to the recipient, and to be investigated. The IGJ adds that temperature outliers are reported by the carrier to the owner of the product and investigated, and that a standard permitted deviation may only be used if product-specific stability data support it. That fixes the division of roles: the carrier supplies the facts, the owner of the product judges whether it is still usable. A courier who decides on its own that a slight excursion does not matter is taking a decision that is not its to take. What exactly should happen in the event of a deviation and what is recorded is explained in temperature excursion during transport; how temperature is measured and recorded in temperature logging in medical transport.

• The carrier reports the deviation immediately to its client and to the recipient, with the measured values, the times and what it has done.
• The client investigates the deviation and decides about the product, if necessary with stability data from the manufacturer.
• The carrier does not deliver as if nothing happened; what happens to the shipment follows the client's decision.
• Report, investigation and decision are recorded in the file of the ride, so that both parties can show afterwards what happened.

A wholesaler or pharmacy that outsources transport manages its own obligation by making the arrangements concrete. These are not extra requirements on top of GDP; they are the requirements of chapters 7 and 9, translated to one carrier and one type of shipment.

• The condition per shipment or product group, with its source: label, manufacturer or your own instruction.
• What you want to see as proof after the ride: actual times, name and role of the recipient, and where agreed the measured temperature.
• To whom the carrier reports a deviation, on which number, also outside office hours.
• Who on your side decides about a shipment with a deviation, and how quickly.
• Whether the carrier drives itself and what happens if it engages someone else.
• When and how you audit: a visit beforehand, access to files, a periodic check.

The carrier can only perform its task if the information is there. If it is missing, that is not a detail but a reason to call before pickup.

• What is being transported and under which condition, with the limit above or below which it becomes a deviation.
• How the shipment is packed and whether there is anything on the packaging to check at pickup.
• The delivery address and the addressee, as on the delivery note, and what to do if the addressee is absent.
• The time window and the contact persons on both sides.
• To whom a deviation is reported and what is then expected of the carrier.
• Which records the client expects and in which form it wants to receive them.

UrgentX Transport is a sole proprietorship. When a ride is driven by another carrier, that happens only after your assessment and approval in advance, as chapter 7 requires, in our system and with the same proof per stop. We hold no wholesale distribution authorisation and we do not claim a GDP certificate as a company; a carrier without a wholesale distribution authorisation cannot obtain one. The driver completed GDP training for transport, and our way of working is built around the transport-related parts of chapter 9: the condition you or the manufacturer prescribe, measurement at pickup and delivery, reporting of deviations and delivery to the addressee. Your quality department can audit us. In the event of a deviation we report immediately, do not deliver without your release and record the deviation in the file. What that means for your shipments in concrete terms is described under transporting medicines in line with GDP and under quality and compliance.